Alvotech, Kashiv Biosciences, and Advanz Pharma announced positive topline results from a phase 3 study of AVT23 (ADL-018), a proposed biosimilar to Xolair® (omalizumab), for Chronic Spontaneous Urticaria (CSU). The study met its primary endpoint, demonstrating therapeutic equivalence and comparable safety between AVT23 and Xolair®. The companies plan to file marketing authorization applications with regulatory agencies.
This positive readout is important because a successful biosimilar to Xolair® could significantly broaden access to a crucial treatment for CSU and potentially other conditions like severe asthma and nasal polyps. Increased competition in the market is likely to drive down prices, making this therapy more affordable and accessible to patients who currently face high costs. This is particularly important in markets where access to biologics is limited by budgetary constraints.
The confirmatory study involved 600 patients with CSU unresponsive to antihistamines. Participants received either 150 mg or 300 mg of AVT23 or Xolair® every four weeks for 24 weeks. The primary endpoint, change from baseline in the weekly Itch Severity Score (ISS7) at Week 12, showed equivalence between the two treatments in the 400-patient 300mg dose group. The UK’s MHRA has already accepted a marketing authorization application, and an EMA filing is expected by year-end.
This successful trial positions AVT23 as a potential competitor in the omalizumab market. Pending regulatory approvals, this biosimilar could reshape the treatment landscape for CSU, offering patients a more affordable alternative and potentially increasing overall market penetration. The partnerships between Alvotech, Kashiv, and Advanz, with their established commercial networks, suggest a robust market entry strategy pending approval. This development reinforces the growing importance of biosimilars in providing cost-effective treatment options for patients worldwide.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
